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Medical technology manufacturer seeks software for quality and process management

IT project from: medical technology manufacturer (Germany)Project no. 19/1750: finished
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Mr. Dipl.-Ing. Olaf Kram
olaf.kram@softguide.de

We are a medical technology manufacturer based in southern Germany and are looking for software for quality and process management. Our company manufactures lithotripters and therapy systems, among other things, in small batch production. We are subject to and work in accordance with ISO standard 13485.

The solution should meet the following requirements:

  • Focus on quality management
  • Process management (customizable processes)
  • Document management
  • Workflows
  • Forms
  • Training
  • Validated system
  • Legally valid electronic signature (Part 11)

Approximately 20 software workstations are planned. Work is carried out in an MS Windows system environment.

Based on the specific requirements, the following solutions can be considered:

WissIntra
ConSense IMS|QMS|PMS
DHC VISION
NO-CODE-BPM (MR.KNOW)
Aeneis - critical and success-relevant processes and assets under control.
CAQ.Net - Quality Management Software Solutions
orgavision

Project statistics

Quantity
Researched solutions 41
Selected potentially relevant solutions (of which published) 26 (12)
Sent e-mails (questions, queries) and telephone calls 52
E-mails received from vendors 12
Direct responses to the IT project 13
Responses classified as relevant 20